Medical Device Regulation (MDR) – Regulatory basis and significance for the pharmaceutical and healthcare industry

What is the Medical Device Regulation (MDR)?

The Medical Device Regulation (MDR), officially known as Regulation (EU) 2017/745, is a comprehensive regulatory basis of the European Union that harmonizes the requirements for medical devices and their placing on the market in the EU. It came into force on May 26, 2021 and replaced the previous Medical Device Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD). The aim of the MDR is to increase patient safety, improve transparency in the industry and put innovations in medical technology on a secure footing.

The MDR defines strict requirements for clinical evaluations, risk management and post-market surveillance (PMS). In addition, a central database called EUDAMED will be introduced to provide all relevant information on medical devices. For the pharmaceutical and healthcare industry in particular, the MDR means increased regulation and requires close cooperation between manufacturers, notified bodies and regulatory authorities.

Relevance of the MDR for the pharmaceutical and healthcare industry

For the pharmaceutical industry, the MDR has a significant impact on combination products, i.e. medical devices that are used in combination with medicinal products, such as ready-to-inject pens, inhalers or prefilled syringes. These products are now subject to both the regulations of the MDR and the Ordinance on Medicinal Products for Human Use (Medical Devices Act and Medical Products Act). Manufacturers must ensure that clinical evaluations and risk assessments cover not only the drug effect, but also the mechanical and physical properties of the medical device.

Some key challenges for pharmaceutical and healthcare companies in connection with the MDR are:

• Increased documentation requirements: The MDR requires more detailed technical documentation and clinical evaluations than previous regulations.
• Stricter market access conditions: Products must provide concrete proof of safety and performance before they are placed on the market.
• Increased post-market surveillance: Companies must ensure that they continue to collect and document safety data after approval.

These changes have a particular impact on pharmaceutical companies that have medical devices as part of their portfolio. A high level of compliance is required to avoid delays or withdrawals from the market.

Important requirements and processes under the MDR

The MDR introduces a large number of new requirements that manufacturers must observe. These include, among others:

• New risk classes and classification rules: The MDR divides medical devices into four risk classes (I, IIa, IIb, III). Many products that were previously classified lower have now been moved to a higher risk category, which means stricter approval requirements.
• Clinical evaluations and post-market surveillance (PMS): Manufacturers are required to provide comprehensive clinical evidence of the safety and performance of their products. Regular post-market surveillance measures ensure that no risks arise even after approval.
• EUDAMED database: The MDR stipulates the use of EUDAMED, a central platform for collecting, storing and analyzing relevant data on medical devices. This increases the transparency and traceability of products.
• Stricter requirements for technical documentation: Companies must provide complete and comprehensive documentation covering design, development and risk management.

These new requirements have a long-term impact on market approval and strategy, particularly for companies with a broad medical device portfolio.

Effects on marketing, sales and product strategy

The Medical Device Regulation not only has a regulatory impact, but also a direct impact on marketing and sales. Pharmaceutical and medical technology companies must adapt their product communication in order to remain MDR-compliant. This affects, among other things:

• Labeling and advertising claims: marketing materials must comply with the new labeling requirements. Inadmissible healing promises or unsubstantiated statements can lead to sanctions.
• Customer education and training: Sales teams must be fully informed about the new requirements in order to advise healthcare professionals correctly.
• Digital transparency through EUDAMED: The MDR makes product information more accessible to customers and authorities. Companies should use this database strategically to build trust.

The strategic challenge is to combine regulatory compliance with effective marketing without delaying market entry or risking lost sales.

Conclusion: The role of the MDR in Pharma-Marketing

The Medical Device Regulation (MDR) poses considerable challenges for the pharmaceutical and healthcare industry, but also offers opportunities. Companies that adapt to the new requirements at an early stage can secure competitive advantages and strengthen the trust of patients and healthcare professionals.

This has the following strategic implications for pharmaceutical marketing:

• Early integration of MDR requirements into product and marketing strategies.
• Transparent communication and training for sales and marketing teams.
• Optimization of advertising and information materials to meet the new regulatory requirements.
• Efficient use of digital platforms such as EUDAMED to strengthen brand presence.

Companies that take a strategic approach to these aspects can not only create legal certainty, but also position themselves as trustworthy market players in the long term.